Who else makes this device?

Name: QuickVue In-Line
Brand: QuickVue In-Line

QuickVue In-Line · Antigens, All Groups, Streptococcus Spp. → Immunology & Microbiology

6manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Zhejiang (3), Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GTY
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Abon Biopharm (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	17
Hangzhou AllTest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11
BD Rapid Diagnostics (Suzhou) Co., Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area		Manufacturer	6

Record

Regulatory record for QuickVue In-Line
Listed by	Quidel Corp., United States
FDA product code	GTY
Device type	Antigens, All Groups, Streptococcus Spp.
Device class	Class 1
Regulation	21 CFR 866.3740
Establishment	Complaint-file establishment, Manufacturer, Exporter
510(k)	K945080
Record published	2019-03-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for QuickVue In-Line
Catalogue number	Size	Status
00345		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
McKesson	Mckesson Medical-Surgical Inc.	5
Sofia	Quidel Corp.	4
QuickVue	Quidel Corp.	4
Cardinal Health	Cardinal Health 200, LLC	3
Strepaim	Germaine Laboratories, Inc.	3
Rapid Response	Btnx Inc.	3
Status Strep A Flip	Princeton BioMeditech Corp.	3
Henry Schein	Henry Schein, Inc.	3
Icon	Beckman Coulter, Inc.	2
Poly stat	Polymedco, Inc.	2
Group B Streptococcus Detection Kit(Immunochromatography)	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	2
Status Strep A Plus	Princeton BioMeditech Corp.	2

Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K171976	2017-12-21
K141775	2014-12-16
K123793	2013-06-17
K011097	2001-05-08
K945080	1995-02-10

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of QuickVue In-Line
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Mckesson Medical-Surgical Inc. Corporate Office	510(k) number	2022-05-25	Class II	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.	a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-04-06	Class II	Under Investigation by firm	Product has the potential for false positive results	12279 units
2025-06-17	Class II	Under Investigation by firm	Dipstick strep A test has potential for false positive results.	22470

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

QuickVue In-Line